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FDA advisers vote to recommend Pfizer RSV vaccine; more data requested

An independent advisory panel voted 7-4, with one abstention.
RSV Vaccines
Posted at 8:46 PM, Feb 28, 2023

A U.S. Federal Drug Administration (FDA) panel of advisers narrowly voted on Tuesday to recommend Pfizer's respiratory syncytial virus (RSV) vaccine for older people over age 60.

The vaccine is now closer to becoming one of the first approved RSV vaccines in the world.

Within the health regulator's Vaccines and Related Biological Products Advisory Committee, made up of what the FDA calls independent outside advisers, there was one abstention as the voting rested at 7-4.

The panel's recommendation of the shot was based on efficacy. Pfizer says the vaccine is a single-dose jab that was shown in trials to lower risk of illness from RSV by at much as 86%.

The Center for Infectious Disease Research and Policy at the University of Minnesota noted that thenarrow tally among advisory members came as concerns were expressed that the vote felt rushed. Some requested more data with the decision coming directly after a particularly bad RSV season.

The virus causes mild respiratory disease and can be severe in older people and infants.

The CDC estimates that between 60,000 and 160,000 adults in the U.S. are hospitalized for symptoms of RSV each year, causing 6,000 to 10,000 documented deaths, the health agencysays.

The advisory committee is expected to meet again on Wednesday to evaluate a similar RSV vaccine from GlaxoSmithKline.